Faculty of Medicine University of Jaffna Version 3 April 2016 · 2017. 2. 16. · The ERC, Faculty of Medicine of University of Jaffna – TOR Version 3; April 2016 Page 5 3. FUNCTIONS

Faculty of Medicine

University of Jaffna

Version 3

April 2016

The ERC, Faculty of Medicine of University of Jaffna – TOR Version 3; April 2016 Page 1


TABLE OF CONTENTS

Page

1. Introduction ………………………………………………………………….........

2. Objectives of the ERC ……………………………………………………….........

3. Functions of the ERC …………………………………………………………......

4. Scope of Responsibilities of the ERC …………………………………………….

5. Status of the ERC …………………………………………………………...…….

6. Accountability of the ERC ………………………………………………………..

7. Composition of the ERC and Appointment of Members ……………………….

7.1. Composition of the ERC ……………………………………………………..

7.2. Terms of Appointment of Members to the ERC ……………………...........

7.3. Orientation of New Members to the ERC ……………………………..........

7.4. Subcommittees …………………………………………………………..........

8. Conduct of Business …………………………………………………………........

8.1. Submission, Notification and Approvals ………………………………........

8.2. Exemption from ethics review ……………………………….........................

8.3. Expedited Review ………………………………………………………….....

8.4. Undergraduate Researches ……………………………………………….....

8.5. Postgraduate Student Researches …………………………………………...

8.6. Collaborative Researches …………………………………………………....

8.7. Ethical clearance ……………………………………………………………..

8.8. Communication of ERC decision ……………………………………………

8.9. Meeting of the ERC ………………………………………………………......

8.10. Records ………………………………………………………………..

9. Post-approval Responsibilities of the ERC ……………………………………...

10. Complaints …………………………………………………………………….......

10.1. Complaints concerning ERC’s Operating Procedures……………….......

10.2. Complaints concerning Conduct of a Project Approved by the ERC ….

10.3. Complaints concerning ERC’s Decision ……………………………….....

11. Review / Amendments of Terms of Reference of the ERC ……………………..

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1. INTRODUCTION

Terms of Reference (TOR) is intended to draw the standards and guidance for the

functioning of the Ethics review committee (ERC) of the Faculty of Medicine,

University of Jaffna which was established to fulfill the ethical responsibilities of

the University concerning research involving human participants and animals of the

region. Its responsibility is to evaluate all ethical aspects of research protocols

submitted to the committee.

Ethical clearance (EC) is essential for human and animal researches involving

pharmaceuticals, medical devices, medical radiation and medical imaging, surgical

procedures, biological samples, medical records, as well as epidemiological, social

and psychological investigations.

2. OBJECTIVES OF THE ERC

The objectives are to:

2.1. protect the interests, rights, welfare, dignity, health and safety of human

participants and animal subjects in research.

2.2. facilitate ethical considerations to research through efficient and effective

review processes.

2.3. facilitate excellence in health research and innovative practices for the

wellbeing of the society by maintaining the ethical standards of human and

animal research. Review in accordance with the relevant guidelines of the

Forum of Ethics Review Committees - Sri Lanka (FERCSL) and other

relevant National and International guidelines.


3. FUNCTIONS OF THE ERC

3.1. Providing independent, competent and timely review of research projects

with respect to their ethical acceptability and granting EC to the research

projects that are scientifically and ethically valid.

3.2. Providing ethical advice for research projects.

3.3. Prescribing the relevant principles and standard procedures that govern

research projects, including those involving tissue samples and/or

personal records.

4. SCOPE OF RESPONSIBILITIES OF THE ERC

4.1. Ensuring that the welfare of the participants is not affected by the research

activities.

4.2. Research protocols submitted to ERC shall be reviewed for ethical

clearance prior to being conducted.

4.3. The ERC is responsible for granting ethical clearance or suggesting

appropriate modification to an application.

4.4. The ERC can withdraw or suspend the ethical clearance given, with

sufficient reasons if necessary.

4.5. Maintaining the minutes and documents relating to reviews, including

decisions, dissents and rationale within the organization.

4.6. The ERC will maintain a continuous contact with the researchers involved

in approved projects by obtaining regular progress reports on updates of

their research and completion reports.

4.7. The ERC may provide support to the researchers for ongoing researches

on ethical issues.


5. STATUS OF THE ERC

5.1. Ethics review committee is an independent subcommittee of the Faculty

Board of Faculty of Medicine, approved by the Senate of the University of

Jaffna to have the authority on behalf of the University of Jaffna to:

give ethical clearance for the conduct of ethically acceptable

research.

suggest amendments to research.

suspend the ethical clearance.

withdraw the ethical clearance given.

6. ACCOUNTABILITY OF THE ERC

6.1. The ERC is accountable to the Board of Faculty of Medicine and the

Senate of the University of Jaffna.

6.2. The extract of the minutes of each ERC meeting shall be forwarded to the

Faculty Board.

6.3. The ERC shall provide an annual report to the Faculty Board at the end of

each calendar year, which shall include information on membership, the

number of protocols reviewed, status of protocols, a description of any

complaints received and their outcome, and general issues raised.

6.4. The ERC may bring, from time to time to the attention of the Dean and the

Faculty Board issues of significant concern.

6.5. The ERC’s Terms of Reference, Standard Operating Procedures and

names and professions of the members shall be available for the public.


7. COMPOSISION OF THE ERC AND APPOINTMENT OF MEMBERS

7.1. Composition of the ERC

7.1.1. The composition of the ERC shall be in accordance with the relevant

Guidelines of the Forum of Ethics Review Committee in Sri Lanka and the

international guidelines:

2-3 persons with expertise in basic medical sciences

2-3 clinicians

At least one (01) person with expertise in the following fields;

Public health research

Biostatistics

Ethics of medical research

Law

Philosophy/Social Science

Biology

Veterinary science

Lay person conversant with social values

7.1.2. Chairperson and a Secretary will be elected from among the members

annually.

7.2. Terms of Appointment of Members to the ERC

7.2.1. Members shall be appointed by the Faculty Board for the period of three

years. They can be reappointed at the end of the term. One third of the

members will be appointed every year to maintain continuity. One third of

the members to be replaced at the end of first and second years will be

determined by the attendance at the meetings i.e. replacement would be

considered for the member absent most.


7.2.2. Membership shall lapse if a member fails to attend three consecutive

meetings of the ERC without excuse. The Chairperson shall notify the

member in writing of such lapse of membership and steps shall be taken to

fill the vacancy of such member.

7.2.3. Each member should give a letter of consent for membership and sign a

confidentiality agreement undertaking;

that all matters of which he/she becomes aware during the course of

his/her work on the ERC shall be kept confidential;

that any conflicts of interest which exist or may arise during his/her

tenure on the ERC shall be declared;

that he/she has not been subject to any criminal conviction or

disciplinary action which may prejudice his/her standing as a ERC

member.

7.2.4. A member may resign from the ERC at any time by giving three months

advance notice in writing to the Chairperson. It will be discussed at the

ERC level and another person can be suggested by the ERC. Later this

notice will be placed at the Faculty Board for approval and filling the

vacancy.

7.2.5. Members must agree to their names and professions being made publicly

available.

7.2.6. Members are not offered remuneration. However, members shall be

reimbursed for legitimate expenses incurred pertaining to ERC activities.

7.2.7. Members may seek leave of absence from the ERC up to 6 months and

those members can suggest the replacement and which will be approved

by the Faculty Board, if appropriate.

7.2.8. A member will be disqualified in the following circumstances:

Disclosure of confidential information


Utilizing the proprietary information

Fails to declare conflict of interest

Evidence for personal or professional misconduct

7.3. Orientation of New Members to the ERC

7.3.1. New ERC members will be provided with adequate orientation.

7.4. Subcommittees

7.4.1. The ERC may appoint sub-committees from the members and / or external

experts whenever necessary.

8. CONDUCT OF BUSINESS

8.1. Submissions, Notifications and Approvals

8.1.1. Guidelines shall be made available to the applicants in the preparation of

their applications.

8.1.2. All applications for ethical clearance must be submitted to the relevant

official of the ERC, by closing date, in writing in the format approved from

time to time by the ERC and shall include such documentation as the ERC

may specify.

8.1.3. The ERC may request the applicant to supply further information in

relation to an application and/or request the applicant to be present at the

meeting of the ERC at which the application shall be considered for the

purpose of providing information and clarification from the ERC

members.

8.1.4. The ERC shall consider every completed application which it receives on

or before 1st of every month at its next available meeting. The secretary

shall circulate the list of completed applications received with the agenda


of the meeting to all members of the ERC at least five (5) days prior to the

next meeting. Incomplete applications shall be returned to the applicants.

8.1.5. A subcommittee consisting the chairperson or nominee, secretary or

nominee and another member of ERC will meet on the first working day

following 1st of each month to appoint the reviewers. For applications

received after 1st of the month will be reviewed at the ERC meeting of the

following month. For each application minimum of 3 primary reviewers

will be appointed by the subcommittee. It is preferable to have all 3

primary reviewers from the members of ERC. If not possible 2 primary

reviewers should be from the ERC members and the third primary reviewer

could be from the pool of external reviewers. The ERC may also obtain

expert opinion when needed.

8.1.6. The reviewers’ comments will be discussed at the very next meeting to

arrive at a decision.

8.1.7. The ERC may take into account the opinions or decisions of another ethics

review committee in relation to a research protocol to arrive at a decision;

8.1.7.1. Decision of another ERC of a research protocol will be

considered in approving or rejecting the protocol.

8.1.7.2. ERC may seek opinion from other ERCs if need arises.

8.1.7.3. To facilitate multi-center research the ERC may:

communicate with any other ERC.

accept a scientific/technical and/or ethical assessment of the

research by another ERC.

8.1.8. The ERC shall promptly notify the applicant its decisions in writing. If the

ERC has granted clearance, it shall inform the applicant in writing that the

research may be commenced. Notification of ERC decisions shall

normally be sent within five (5) working days.


8.1.9. Response from the principal investigator (PI) to ERC’s comments should

be received within 3 months from the date of communication of ERC. If

the PI does not respond within 3 months the application concerned will

lapse. In such circumstance if the ethical clearance is desired for the same

project a fresh application has to be submitted.

8.1.10. The PI should send progress reports at the end of each year if the project

duration is more than one year and the completion report should be sent at

the end of the completion of the project to ensure compliance of ethical

issues.

8.2. Exemption from ethical review

The ERC may exempt from ethics review audits, surveys and research with

no risk to the participants provided that human participants involved will

not be identified directly or indirectly.

8.3. Expedited review

8.3.1. The ERC will consider for expedited review of the projects with minimal

risk and non-sensitive issues such as collection of secondary data, Studies

on the effectiveness of educational methods and curricula, projects

evaluating the public benefits of existing programmes and impact of

changes in programmes without intervention.

8.3.2. The ERC may establish a subcommittee, consisting of at least the

Chairperson (or nominee), Secretary (or nominee) and another ERC

member may undertake expedited review of research protocols between

scheduled meetings at the discretion of the Chairperson. The subcommittee

may seek advice from other ERC members, as appropriate, before reaching

a decision. If ethical clearance is granted, it shall be considered for

ratification at the next ERC meeting.


8.3.3. The subcommittee may consider other applications for expedited review

that are considered to be of minimal risk to participants such as expected

non serious adverse events, protocol reports, minor amendments and the

like. The minutes of any such meetings shall be tabled for ratification at

the next ERC meeting.

8.4. Undergraduate Researches

8.4.1. Applications must be submitted under the responsibility of a qualified

supervisor.

8.4.2. Undergraduate research projects should come through the department

concerned.

8.4.3. Such projects are reviewed by the subcommittee comprising the

Chairperson and secretary of ERC and an expert from the department

concerned.

8.4.4. Decision of the ERC will be communicated to the Head of the concerned

Department.

8.4.5. Once the ethical clearance is given the department concerned will be

responsible for the conduct and monitoring of the project.

8.5. Postgraduate Student Researches

8.5.1. Postgraduate student proposals should be submitted under the

responsibility of a qualified supervisor (unless the researcher is a senior

lecturer in a University, exempted from working under a supervisor) with

a covering letter indicating:

a. the degree to be obtained

b. the institution where the candidate is registered

c. a brief account on the procedure of approving the project at that

institution


8.6. Collaborative Researches

8.6.1. In the case of international collaborative researches following documents

should be submitted with the application;

8.6.1.1. Evidences for prior agreement between the local and foreign

collaborator on the following;

Fate of data and samples/ specimens.

Ownership of the data and publication and intellectual property

rights.

Nature of benefits and their distribution.

8.6.1.2. Ethical clearance certificate from the country of collaborator.

8.6.2. Transfer of biological or genetic materials should follow the standards

drawn by this country.

8.6.3. The ownership of the data and right of publication should lie with the

researcher who collects the data. In the case of multicenter research data

must be pooled for publication, but, researchers from Sri Lanka should be

allowed to publish data collected by them that of relevance to this country.

8.7. Ethical clearance

The ethical clearance is given for a period of one year which could be

extended/ renewed. Extension or renewal would be considered only on

receiving the progress report and on request by the PI.

8.8. Communication of the ERC decision

The decision of the ERC on research projects will be informed to the PI in

writing signed by Chairperson and secretary. Notification of the ERC

decisions shall normally be sent within five (5) working days after the

meeting.


8.9. Meetings of ERC

8.9.1. A quorum must be present in order for the ERC to reach a final decision

on any agenda item. A quorum for the meeting of ERC is at least five (5)

members to arrive at a decision (at least one member with primary area of

expertise is in a non-scientific area).

8.9.2. The ERC shall be free to consult any outside expert to provide advice and

assistance in the review of any research protocol submitted to it subject to

the person(s) having no conflict of interest.

8.9.3. ERC meets on a regular basis, which is normally at monthly intervals.

8.9.4. Meeting dates and agenda will be circulated to members.

8.9.5. Any member of the ERC who has any interest, financial or otherwise, in a

protocol or other related matter(s) considered by the ERC, should declare

such interest as soon as practicable. The member will not participate in the

discussions and will not involve in the decision making with respect to the

matter. All declarations of interest and abstinence of the member

concerned will be recorded.

8.9.6. The ERC will endeavor to reach a decision concerning the ethical

acceptability of a protocol by consensus. Where a decision cannot be

reached, the decision will be taken by a majority of two-thirds of the

members present.

8.10. Records

8.10.1. The secretary and a designated official of the ERC shall prepare and

maintain written records of the ERC’s activities, including agendas and

minutes of all meetings of the ERC.

8.10.2. The secretary and/or a designated official of the ERC shall prepare and

maintain a file for each application received including a copy of the


application, and any relevant correspondence including that between the

applicant and the ERC.

8.10.3. Files shall be kept securely and confidentially.

8.10.4. Records shall be held for sufficient time to allow future reference. The

minimum period for retention is at least five years from the date of

completion of a project but for specific types of research, such as clinical

trials, 15years shall apply. Files which are no longer required for retention

shall be electronically archived.

8.10.5. The ERC shall maintain a register of all the applications received and

reviewed in accordance with the Guidelines of the Forum of Ethics Review

Committees-Sri Lanka and other relevant national and international

guidelines.

9. POST-APPROVAL RESPONSIBILITIES OF THE ERC

9.1. The ERC will, as a condition of approval of each project, require that

investigators immediately report any significant changes which might

warrant review of ethical approval of the project, including:

proposed changes in the research protocol or conduct.

unforeseen events that might affect continued ethical acceptability

of the project.

10. COMPLAINTS

10.1. Complaints concerning ERC’s Operating Procedures

10.1.1. Any concern or complaint about the ERC’s review process should be

directed to the attention of the Chairperson of the ERC, detailing it in

writing. The Chairperson will investigate the complaint and its validity,

and make a recommendation to the ERC on the appropriate course of


action. If the complainant is not satisfied with the outcome of the

Chairperson’s investigation, then he/she can refer the complaint to the

Dean/ the Vice chancellor. The Chairperson will provide to the Dean/the

Vice chancellor or his/her nominee all relevant information about the

complaint/concern and the course of action. The Dean/ the Vice Chancellor

or his/her nominee will determine whether there is to be a further

investigation into the complaint. If it is decided that there is to be any

further investigation, then the Dean/ the Vice Chancellor or his/her

nominee will convene a suitable panel to review the complaint, ensuring

that both the complainant and the ERC are afforded the opportunity to

make submissions.

10.1.2. In conducting its review, the panel shall be concerned with ascertaining

whether the ERC acted in accordance with TOR and then the National

guidelines.

10.1.3. Community complaint from third party or subject can be submitted to

chairperson of ERC or to the Dean/ the Vice Chancellor.

10.2. Complaints concerning the Conduct of a Project Approved by the

ERC

10.2.1. Any concern or complaint about the conduct of a project should be

directed to the secretary of the ERC. When complaint is received the

secretary shall notify the Chairperson as soon as possible and at the

subsequent meeting of ERC a subcommittee will be formed comprising

minimum of three members to investigate the complaint. The

subcommittee of the ERC shall investigate the complaint and make

necessary recommendations on the appropriate course of action and report

at the subsequent meeting of the ERC. If the complainant is not satisfied


with the outcome of the subcommittee’s investigation, then he/she can

refer the complaint to the Dean/ the Vice Chancellor.

10.3. Complaints concerning the ERC’s Decision

10.3.1. The Principal Investigator may submit a written request with an

explanation for reconsideration of an ERC decision not granting ethical

clearance. The Chairperson and ERC will refer documentation and

supporting materials from the Principal Investigator to other members of

the ERC for discussion at its next meeting. The ERC will review the

written documents and, if necessary, an informal meeting of the ERC and

the Principal Investigator will be held. Considering all additional

information, the ERC will render a decision on whether to change its

original position. Every attempt will be made by the ERC, in consultation

with the Principal Investigator, to reach a resolution a meeting between the

principal investigator and the ERC will be arranged. Appeal of an ERC

decision in the event, if the matter cannot be resolved at the meeting, an

appeal may be made to the Dean/ the Vice-Chancellor.

10.3.2. A person with a complaint about the ERC’s rejection of his/her

application should bring the complaint to the attention of the Chairperson

of the ERC, detailing the grounds of the complaint. Complaints may also

be made to the Vice Chancellor. The Chairperson shall notify the Vice

Chancellor of the complaint as soon as possible. The Vice Chancellor shall

notify the Chairperson of any complaints received by him/ her as soon as

possible. The Chairperson shall investigate the complaint and its validity,

and recommend to the ERC on the appropriate course of action at its next

meeting. At the Chairperson’s discretion, the complainant may be invited

to attend the next ERC meeting, or the complainant may request the


opportunity to attend. The complainant shall be informed of the ERC’s

response in writing, normally within seven (7) working days of the ERC

meeting. If the complainant is not satisfied with the action taken by the

ERC, then he / she can refer the complaint to the Vice Chancellor or

request the Chairperson to do so. The Chairperson shall provide to the Vice

Chancellor all relevant information about the complaint. The Vice

Chancellor shall determine whether there is to be a further investigation of

the complaint. If it is decided that there is a valid case for investigation,

then the Vice Chancellor shall convene a suitable panel to review the

complaint, ensuring that both the complainant and the ERC are afforded

the opportunity to make submissions. The outcomes of this process may

include:

The complaint/concern is dismissed.

The complaint/concern is referred back to the ERC for consideration,

bearing in mind the findings of the panel.

The application may be referred for external review by an independent

ERC if the Vice Chancellor concludes that due process has not been

followed by the ERC in reaching its decision.

10.3.3. Should the ERC be requested to review its decision, then the outcome

of this review by the ERC shall be final. In accordance with section 5, the

panel or the Vice Chancellor cannot substitute its approval for the approval

of the ERC.


11. REVIEW / AMENDMENT OF TERMS OF REFERENCE OF ERC

11.1. The ERC shall review the Terms of Reference once in 2 years and propose

changes to the Faculty Board for approval if appropriate.

11.2. Members of the ERC may from time to time propose changes to the Terms

of Reference for review by the ERC. If considered acceptable, such

changes shall be forwarded to the Faculty Board for approval if

appropriate.

Documents

Faculty of Medicine University of Jaffna Version 3 April 2016 · 2017. 2. 16. · The ERC, Faculty of Medicine of University of Jaffna – TOR Version 3; April 2016 Page 5 3. FUNCTIONS